MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-06-05 for BIO INSTABILITY DRILL GUIDE SERRATED C6172 manufactured by Conmed Linvatec Corp.
[453345]
During a bankhardt repair that metal shavings were noted in the joint and that the surgeon was not able to retrieve all metal shavings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2006-00217 |
| MDR Report Key | 723412 |
| Report Source | 05,07 |
| Date Received | 2006-06-05 |
| Date of Report | 2006-05-05 |
| Date of Event | 2006-05-02 |
| Date Mfgr Received | 2006-05-05 |
| Date Added to Maude | 2006-06-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC CORPORATION |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO INSTABILITY DRILL GUIDE SERRATED |
| Generic Name | DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2006-06-05 |
| Returned To Mfg | 2006-05-09 |
| Model Number | NA |
| Catalog Number | C6172 |
| Lot Number | 0000612A |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 712492 |
| Manufacturer | CONMED LINVATEC CORP |
| Manufacturer Address | * LARGO FL * US |
| Baseline Brand Name | BIO INSTABILITY DRILL GUIDE SERRATED |
| Baseline Generic Name | DRILL GUIDE |
| Baseline Model No | NA |
| Baseline Catalog No | C6172 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-05 |